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Sofosbuvir and Velpatasvir

Sofosbuvir and velpatasvir is a once-daily combination antiviral that treats chronic hepatitis C virus (HCV) infection, genotypes 1 through 6, in adults and children 3 years and older.

Brand name Epclusa
Drug classes Hepatitis C Virus Ns5a Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Sofosbuvir and Velpatasvir at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Sofosbuvir and velpatasvir (Epclusa) is a once-daily treatment for chronic hepatitis C of every strain (genotype), blocking two proteins the virus needs to copy itself (NS5B polymerase and NS5A); on the market since about 2016 and now available as a generic, it is a standard first choice that cures most people, usually over 12 weeks. Most people tolerate it well, and the side effects they notice are usually headache and tiredness. Its boxed warning is about hepatitis B, which can flare up during or after treatment in anyone who has or once had it, sometimes causing liver failure or death, so a hepatitis B test comes first.

Clinical pearls

  • Amiodarone, a heart rhythm drug, is not recommended with it because the pair can cause a dangerously slow heart rate.
  • St. John's wort, rifampin, carbamazepine and phenytoin can make it work less well, so show your pharmacist every medicine and supplement first.
  • Omeprazole-type heartburn drugs are not recommended with it, and antacids should be taken 4 hours apart from it.
  • On warfarin or diabetes medicines, expect closer checks, since clearing the virus can shift INR (a clotting test) and blood sugar.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

If you have both hepatitis C and hepatitis B (or had hepatitis B in the past), hepatitis B can flare up again during or after hepatitis C treatment. In some cases this has caused sudden severe liver inflammation, liver failure and death.

You should be tested for hepatitis B before starting. If there is any sign of hepatitis B infection, your doctor will monitor you during treatment and afterward, and treat hepatitis B if needed. Report any new or worsening liver symptoms to your doctor right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Other oral form
Earliest FDA record2016
Companies listing it with the FDA2
FDA label last updatedJun 5, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Sofosbuvir and Velpatasvir, written from its FDA label.

What Sofosbuvir and Velpatasvir is used for

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Sofosbuvir and velpatasvir treats chronic hepatitis C virus (HCV) infection.

  • Adults and children 3 years and older with HCV genotype 1, 2, 3, 4, 5, or 6 (Epclusa and sofosbuvir and velpatasvir tablets).
  • People without cirrhosis or with compensated cirrhosis.
  • People with decompensated cirrhosis, together with ribavirin.
  • Epclusa oral pellets are an option for children who are 3 years and older.

How Sofosbuvir and Velpatasvir works

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This medicine is a fixed-dose combination of two direct-acting antivirals. Sofosbuvir is an NS5B polymerase inhibitor, meaning it blocks an enzyme the hepatitis C virus uses to copy itself. Velpatasvir is an NS5A inhibitor, which blocks another protein the virus needs. Together they attack the virus in two ways.

Sofosbuvir and Velpatasvir dosage

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Adults take one tablet by mouth once a day, with or without food, usually for 12 weeks. Children 3 and older take weight-based doses. Children under 6 should take Epclusa oral pellets with food.

  • If used with ribavirin, ribavirin is taken with food.
  • No dose change is recommended for kidney or liver impairment, or for older adults.
  • Follow your prescriber and the label for missed doses.

Dosing details from the FDA-approved label

From the Sofosbuvir and Velpatasvir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Treatment-naïve and treatment-experienced adults and pediatric patients 3 years and older with genotype 1, 2, 3, 4, 5, or 6 HCV, without cirrhosis and with compensated cirrhosis (Child-Pugh A)
    • EPCLUSA (sofosbuvir and velpatasvir) 12 weeks
    • Adults: one tablet (400 mg sofosbuvir and 100 mg velpatasvir) taken orally once daily with or without food
    • No dosage adjustment in any degree of renal impairment, including dialysis; same regimen for HCV/HIV-1 coinfection
  • Treatment-naïve and treatment-experienced patients with decompensated cirrhosis (Child-Pugh B or C)
    • EPCLUSA + ribavirin 12 weeks
    • Ribavirin 1,000 mg per day for patients less than 75 kg and 1,200 mg for those weighing at least 75 kg, divided and administered twice daily with food
    • Ribavirin starting and on-treatment dosage can be decreased based on hemoglobin and creatinine clearance
  • Treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
    • EPCLUSA once daily for 12 weeks
  • Pediatric patients 3 years and older, body weight less than 17 kg
    • 150 mg/37.5 mg per day: one 150 mg/37.5 mg packet of pellets once daily
    • Tablet N/A; for patients less than 6 years of age administer oral pellets with food
  • Pediatric patients 3 years and older, body weight 17 to less than 30 kg
    • 200 mg/50 mg per day: one 200 mg/50 mg packet of pellets once daily or one 200 mg/50 mg tablet once daily
    • For patients less than 6 years of age administer oral pellets with food
  • Pediatric patients 3 years and older, body weight at least 30 kg
    • 400 mg/100 mg per day: two 200 mg/50 mg packets of pellets once daily or one 400 mg/100 mg tablet once daily
    • Two 200 mg/50 mg tablets once daily can be used for patients who cannot swallow the 400 mg/100 mg tablet
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Testing prior to the initiation of therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) See recommended treatment regimen and duration in patients 3 years of age and older with genotypes 1, 2, 3, 4, 5, or 6 HCV in table below: ( 2.2 ) Patient Population Regimen and Duration Treatment-naïve and treatment-experienced In clinical trials, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). , without cirrhosis and with compensated cirrhosis (Child-Pugh A) Sofosbuvir and velpatasvir 12 weeks Treatment-naïve and treatment-experienced , with decompensated cirrhosis (Child-Pugh B and C) Sofosbuvir and velpatasvir + ribavirin 12 weeks Recommended dosage in adults: One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food. ( 2.3 ) Recommended dosage in pediatric patients 3 years and older: Recommended dosage is based on weight. Refer to Table 2 of the full prescribing information for specific dosing guidelines based on body weight. ( 2.4 ) For pediatric patients less than 6 years of age, administer sofosbuvir and velpatasvir (EPCLUSA) oral pellets with food. ( 2.4 ) Instructions for Use should be followed for preparation and administration of sofosbuvir and velpatasvir (EPCLUSA) oral pellets. ( 2.5 ) HCV/HIV-1 coinfection: For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the table above. ( 2.2 ) For treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), the recommended regimen is sofosbuvir and velpatasvir once daily for 12 weeks. ( 2.2 ) If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications. ( 2.3 , 2.4 ) For patients with renal impairment including end stage renal disease on dialysis, follow the dosage recommendations in the table above. ( 2.6 ) 2.1 Testing Prior to the Initiation of Therapy Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with sofosbuvir and velpatasvir [see Warnings and Precautions (5.1) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Sofosbuvir and Velpatasvir side effects

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Most side effects are mild. The most common ones are:

Common side effects

  • Headache
  • Fatigue (tiredness)
  • Nausea
  • Weakness (asthenia)
  • Trouble sleeping (insomnia)
  • Diarrhea
  • Anemia (low red blood cells), when taken with ribavirin
  • Vomiting or spitting up the medicine in children under 6

When to get medical help

  • Call your doctor right away if you have signs of hepatitis B flaring up, such as new or worsening liver problems, especially if you have or ever had hepatitis B.
  • Get medical help immediately if you take amiodarone and have near-fainting, fainting, dizziness, lightheadedness, unusual weakness or tiredness, shortness of breath, chest pain, confusion or memory problems. These can be signs of a dangerously slow heart rate (bradycardia).
  • If you have diabetes, tell your doctor about any symptoms of low blood sugar. Blood sugar control can change as hepatitis C clears.
  • If you take warfarin, expect extra blood tests (INR) during treatment.

Sofosbuvir and Velpatasvir warnings and precautions

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The biggest risk is hepatitis B reactivation in people infected with both hepatitis C and hepatitis B. It has led to liver failure and death. Everyone is tested before starting.

  • Amiodarone can cause serious slow heart rate. It is not recommended with this medicine.
  • Drugs like rifampin, carbamazepine and St. John's wort can make it less effective.
  • Ribavirin warnings also apply if you take them together.
  • As hepatitis C clears, blood sugar and clotting (INR) may change, so some medicines may need adjusting.

Sofosbuvir and Velpatasvir interactions

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Several drugs and supplements can clash with this medicine.

  • Amiodarone: risk of dangerously slow heart rate.
  • Rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, St. John's wort: lower its levels.
  • Efavirenz and tipranavir/ritonavir: lower its levels.
  • Omeprazole and other proton-pump inhibitors: less absorption of velpatasvir.
  • Antacids: take 4 hours apart.
  • Rosuvastatin and atorvastatin: higher risk of muscle damage.
  • Digoxin, tenofovir and topotecan: levels increase.
  • Diabetes medicines and warfarin: may need monitoring and adjustment.

Interactions listed in the FDA-approved label

From the Sofosbuvir and Velpatasvir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • P-gp inducers and/or moderate to strong CYP inducers (e.g., rifampin, St. John's wort, carbamazepine): May decrease concentrations of sofosbuvir and/or velpatasvir. Use is not recommended.
  • Antacids (e.g., aluminum and magnesium hydroxide): Drugs that increase gastric pH are expected to decrease concentration of velpatasvir. Separate antacid and sofosbuvir and velpatasvir administration by 4 hours.
  • H2-receptor antagonists (e.g., famotidine): Drugs that increase gastric pH are expected to decrease concentration of velpatasvir. May be administered simultaneously with or 12 hours apart from sofosbuvir and velpatasvir at a dose not exceeding doses comparable to famotidine 40 mg twice daily.
  • Proton-pump inhibitors (e.g., omeprazole): Drugs that increase gastric pH are expected to decrease concentration of velpatasvir. Coadministration not recommended; if medically necessary, give sofosbuvir and velpatasvir with food and 4 hours before omeprazole 20 mg. Use with other proton-pump inhibitors has not been studied.
  • Amiodarone: Coadministration with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia; mechanism unknown. Not recommended; if coadministration is required, cardiac monitoring is recommended.
  • Digoxin: Increases digoxin concentration. Therapeutic concentration monitoring of digoxin is recommended.
  • Topotecan: Increases topotecan concentration. Coadministration is not recommended.
  • Anticonvulsants (carbamazepine, phenytoin, phenobarbital), antimycobacterials (rifabutin, rifampin, rifapentine), tipranavir/ritonavir, St. John's wort: Decrease sofosbuvir and velpatasvir concentrations. Coadministration is not recommended.
  • Rosuvastatin: May significantly increase rosuvastatin concentration, increasing risk of myopathy, including rhabdomyolysis. Rosuvastatin may be administered at a dose that does not exceed 10 mg.
  • Efavirenz-containing regimens, tenofovir DF regimens, atorvastatin: Efavirenz decreases velpatasvir; tenofovir DF increases tenofovir; atorvastatin may increase risk of myopathy, including rhabdomyolysis. Efavirenz: not recommended. Tenofovir DF: monitor for tenofovir-associated adverse reactions. Atorvastatin: monitor closely for myopathy and rhabdomyolysis.
Read the label’s full interactions text

7 DRUG INTERACTIONS P-gp inducers and/or moderate to strong CYP inducers (e.g., rifampin, St. John's wort, carbamazepine): May decrease concentrations of sofosbuvir and/or velpatasvir. Use of sofosbuvir and velpatasvir with P-gp inducers and/or moderate to strong CYP inducers is not recommended. ( 5.3 , 7 ) Consult the full prescribing information prior to use for potential drug interactions. ( 5.2 , 5.3 , 7 ) Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. ( 7.3 ) 7.1 Potential for Other Drugs to Affect Sofosbuvir and Velpatasvir Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP while GS-331007 (the predominant circulating metabolite of sofosbuvir) is not. In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8, and CYP3A4 was observed. Drugs that are inducers of P-gp and/or moderate to strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g., rifampin, St. John's wort, carbamazepine) may decrease plasma concentrations of sofosbuvir and/or velpatasvir, leading to reduced therapeutic effect of sofosbuvir and velpatasvir. The use of these agents with sofosbuvir and velpatasvir is not recommended [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] . Sofosbuvir and velpatasvir may be coadministered with P-gp, BCRP, and CYP inhibitors. 7.2 Potential for Sofosbuvir and Velpatasvir to Affect Other Drugs Velpatasvir is an inhibitor of drug transporters P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, and OATP2B1. Coadministration of sofosbuvir and velpatasvir with drugs that are substrates of these transporters may increase the exposure of such drugs.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Sofosbuvir and Velpatasvir

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  • Get tested for hepatitis B before starting.
  • Do not use with ribavirin if you are pregnant or your female partner is pregnant.
  • Tell your doctor if you are pregnant or breastfeeding.
  • Not studied in children under 3.
  • No dose adjustment for older adults, kidney impairment (including dialysis) or liver impairment.
  • Share all your medicines and supplements with your care team.

Sofosbuvir and Velpatasvir overdose

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There is no specific antidote for an overdose. You would be monitored for signs of toxicity and given general supportive care, including checks of vital signs. Dialysis removes the main sofosbuvir metabolite but is unlikely to remove velpatasvir.

What Sofosbuvir and Velpatasvir does in the body

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In heart rhythm studies, sofosbuvir at 3 times the recommended dose and velpatasvir at 5 times the recommended dose did not prolong the QTc interval (a measure of heart rhythm timing) to any clinically relevant extent.

How your body processes Sofosbuvir and Velpatasvir

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Sofosbuvir peaks in the blood within about 0.5 to 1 hour and velpatasvir in about 3 hours. Food can be taken with or without the medicine. Sofosbuvir is broken down into a main metabolite called GS-331007 and cleared mostly in urine. Velpatasvir is cleared mainly through bile and feces. Velpatasvir is processed by liver enzymes (CYP2B6, CYP2C8, CYP3A4).

How to store Sofosbuvir and Velpatasvir

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Store below 30 °C (86 ºF).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

147

Supplements & herbs that interact with Sofosbuvir and Velpatasvir

147 supplements and herbal products have documented interactions with Sofosbuvir and Velpatasvir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 108
  • Minor · 36
Every supplement checked against Sofosbuvir and Velpatasvir — ranked by severity The full interaction hub: 3 major · 108 moderate · 36 minor · every one linked to its full report. Check Sofosbuvir and Velpatasvir against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Sofosbuvir and Velpatasvir: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Sofosbuvir and Velpatasvir — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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It treats chronic hepatitis C infection, genotypes 1 through 6, in adults and children 3 and older. For people whose cirrhosis is decompensated, it is taken together with ribavirin.

How do I take it?

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Adults take one tablet by mouth once a day, with or without food. Treatment usually lasts 12 weeks. Take it as your prescriber directs.

Why do I need a hepatitis B test first?

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Hepatitis B can flare up again during or after hepatitis C treatment, sometimes seriously. Testing lets your doctor watch you closely or treat hepatitis B if needed.

What side effects should I expect?

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The most common are headache and tiredness. Some people also have nausea, weakness, or trouble sleeping. With ribavirin, anemia and diarrhea are more common.

Are there medicines or supplements I should avoid?

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Yes. Avoid St. John's wort. Amiodarone, rifampin and carbamazepine are also not recommended with this medicine. Tell me about everything you take, including acid reducers, statins and diabetes medicines.

Can I take it if I'm pregnant?

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There are not enough human data to know if it affects pregnancy. If it is combined with ribavirin, it must not be used in pregnancy or by men whose partners are pregnant. Talk to your doctor before starting.

Is Sofosbuvir and Velpatasvir available over the counter?

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No. Sofosbuvir and Velpatasvir is a prescription medicine: every Sofosbuvir and Velpatasvir product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Sofosbuvir and Velpatasvir first available?

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The earliest FDA record we hold for Sofosbuvir and Velpatasvir is from 2016: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Sofosbuvir and Velpatasvir was first used.

Who makes Sofosbuvir and Velpatasvir?

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2 companies currently list Sofosbuvir and Velpatasvir products in the FDA's NDC Directory, including Gilead Sciences, Inc., Asegua Therapeutics LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Sofosbuvir and Velpatasvir on HelloPharmacist

Detailed data & references for Sofosbuvir and Velpatasvir Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Sofosbuvir and Velpatasvir forms and strengths (how it comes)

Sofosbuvir and Velpatasvir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Epclusa
How this form is used
What it may be used for
  • Epclusa tablets and sofosbuvir and velpatasvir tablets are used in adults and children 3 years and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection.
  • Epclusa and sofosbuvir and velpatasvir are used with ribavirin for decompensated cirrhosis.
Important instructions
  • Epclusa and sofosbuvir and velpatasvir tablets are taken by mouth once daily, with or without food.
  • For Epclusa and sofosbuvir and velpatasvir, the usual treatment length is 12 weeks.
  • In children, Epclusa and sofosbuvir and velpatasvir doses are based on body weight.
Available strengths 4 strengths
7 FDA-listed product records ⓘ

Other oral form

By mouth
Brands Epclusa
How this form is used
What it may be used for
  • Epclusa oral pellets are used in children 3 years and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection.
Important instructions
  • Epclusa oral pellets are taken once daily, with or without food, for children 3 and older.
  • For children under 6, Epclusa oral pellets should be given with food.
  • Follow the Instructions for Use to prepare and give Epclusa oral pellets.
Available strengths 4 strengths
4 FDA-listed product records ⓘ

Sofosbuvir and Velpatasvir on the U.S. market: products, makers and brands

How Sofosbuvir and Velpatasvir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 5 Sofosbuvir and Velpatasvir product records with the FDA, mostly as tablet, other oral form; the earliest marketing or approval year on record is 2016. Brand names on the directory include Epclusa; the rest are generics.

2
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
2
Brand names
5
FDA-listed product records ⓘ
2016
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Gilead Sciences, Inc.80%
Asegua Therapeutics LLC20%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Sofosbuvir and Velpatasvir is used (Medicaid data)

A general measure of how commonly Sofosbuvir and Velpatasvir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Sofosbuvir and Velpatasvir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

47,731
Medicaid prescriptions filled (Q1–Q4 2025)
$414.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sofosbuvir and Velpatasvir prescribed? Of the 1,601 medications we measure, Sofosbuvir and Velpatasvir ranks #641 by Medicaid prescriptions — more than 60% of them.

Where Sofosbuvir and Velpatasvir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Sofosbuvir and Velpatasvir product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 400 mg / 100 mg oral tablet is the most-dispensed Sofosbuvir and Velpatasvir product — about 100% of these Medicaid prescriptions.

sofosbuvir 400 MG / velpatasvir 100 MG Oral Tablet Most dispensed

47,720 Medicaid prescriptions (Q1–Q4 2025) 100% of Sofosbuvir and Velpatasvir prescriptions shown $414.1M gross reimbursement (before rebates) ≈ $8,677 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1799212

sofosbuvir 200 MG / velpatasvir 50 MG Oral Pellet

11 Medicaid prescriptions (Q1–Q4 2025) <1% of Sofosbuvir and Velpatasvir prescriptions shown $373,915 gross reimbursement (before rebates) ≈ $33,992 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2584200

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sofosbuvir and Velpatasvir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 5 listed Sofosbuvir and Velpatasvir NDCs with Medicaid activity.

Compare Sofosbuvir and Velpatasvir products

A representative set of FDA-listed product records for Sofosbuvir and Velpatasvir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Other oral form
VELPATASVIR 37.5 mg/1; SOFOSBUVIR 150 mg Oral Gilead Sciences, Inc. NDA View NDC →
VELPATASVIR 50 mg/1; SOFOSBUVIR 200 mg Oral Gilead Sciences, Inc. NDA View NDC →
💊Tablet
VELPATASVIR 100 mg/1; SOFOSBUVIR 400 mg Oral Asegua Therapeutics LLC NDA AUTHORIZED GENERIC View NDC →
VELPATASVIR 50 mg/1; SOFOSBUVIR 200 mg Oral Gilead Sciences, Inc. NDA View NDC →
VELPATASVIR 100 mg/1; SOFOSBUVIR 400 mg Oral Gilead Sciences, Inc. NDA View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Sofosbuvir and Velpatasvir NDCs →

Sofosbuvir and Velpatasvir recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Sofosbuvir and Velpatasvir recalls since July 2021.

✅No Sofosbuvir and Velpatasvir recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Sofosbuvir and Velpatasvir RxCUI 1799211 2 dose forms · 4 strengths

Look up RxCUI 1799211 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Sofosbuvir and Velpatasvir costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 400; 100 mg/1; mg $865.89 per tablet NDC details & price history
Tablet, Film Coated · Oral VELPATASVIR 100 mg/1; SOFOSBUVIR 400 mg $865.89 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Sofosbuvir and Velpatasvir brand names

Sofosbuvir and Velpatasvir is sold under one brand name in the FDA directory — Epclusa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Epclusa

Who makes Sofosbuvir and Velpatasvir: manufacturers and labelers

2 companies list Sofosbuvir and Velpatasvir products with the FDA. By number of product records, the largest are Gilead Sciences, Inc., Asegua Therapeutics LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Gilead Sciences, Inc. 4 Asegua Therapeutics LLC 1

Sofosbuvir and Velpatasvir drug class (RxNorm)

Sofosbuvir and Velpatasvir belongs to the Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor class.

Pharmacologic class Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Drug family (ATC) Antivirals for treatment of HCV infections
How it works RNA Replicase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Sofosbuvir and Velpatasvir page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 5, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sofosbuvir and Velpatasvir.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Sofosbuvir and Velpatasvir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
5
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Gilead Sciences, Inc.
Linked label effective
Jun 5, 2024
Composite sections available
24
Linked SPL Set ID
7f30631a-ee3b-4cfe-866b-964df3f0a44f
Linked SPL Document ID
4e28b652-df20-450d-9f6e-4cc6e355e223
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Gilead Sciences, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →